What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole, ropinirole) and levodopa, often cause side effects like nausea, dizziness, orthostatic hypotension, and somnolence. Dopamine agonists can also lead to impulse control disorders, including compulsive gambling and hypersexuality. Levodopa may cause motor complications such as dyskinesia and 'wearing off' phenomena. Cholinesterase inhibitors, used for cognitive symptoms, can worsen tremors and cause nausea and vomiting. These side effects necessitate careful monitoring and individualized treatment adjustments.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Parkinson's Disease, focusing on dopaminergic therapies. These include levodopa, often combined with carbidopa, which remains the most effective treatment for motor symptoms. Dopamine agonists such as pramipexole, ropinirole, and the rotigotine transdermal system have also been approved and are used to stimulate dopamine receptors directly. Additionally, MAO-B inhibitors like selegiline and rasagiline help to prevent the breakdown of dopamine. While Tavapadon, a Dopamine D1/D5 receptor partial agonist, is still under study, these existing treatments provide a broad framework for managing Parkinson's Disease symptoms.

What other types of research exist?

Promising novel alternatives to Tavapadon for Parkinson's Disease patients include the D3/D2 dopamine receptor agonist S32504, which may offer advantages over L-dopa and primarily acts through D2 receptors. Additionally, the noncompetitive AMPA-receptor antagonist Perampanel has shown efficacy in reducing motor symptoms and managing 'wearing off' motor fluctuations in advanced PD.

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Dopamine Agonist

Tavapadon for Parkinson's Disease (TEMPO-2 Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by Cerevel Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sexually active men or women of childbearing potential must agree to use acceptable or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment

Participants who are capable of giving signed informed consent and complying with the requirements and restrictions listed in the informed consent form and in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 31 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called tavapadon to see if it can help people with Parkinson's Disease. The study will check how well the medication works, how safe it is, and how the body processes it. Tavapadon aims to balance brain chemicals that control movement, potentially reducing Parkinson's symptoms.

Who is the study for?

This trial is for men and women aged 40-80 with early Parkinson's Disease (PD) who need medication to manage their condition. They must not have used PD medications recently, agree to birth control if applicable, and be able to follow the study rules. People with dementia, significant heart issues, drug abuse history, or certain other health problems can't join.

What is being tested?

The trial is testing tavapadon against a placebo in people with early PD. It aims to see how well tavapadon works and its effects on the body when doses are adjusted based on patients' needs compared to no active treatment.

What are the potential side effects?

While specific side effects of tavapadon aren't listed here, common ones may include nausea, dizziness, sleepiness or insomnia which are typical for drugs affecting brain function like those used in PD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use effective birth control or remain abstinent during and 4 weeks after the trial.

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I can sign the consent form and follow the study's requirements.

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You have been diagnosed with Parkinson's disease according to specific criteria from the UK Parkinson's Disease Society Brain Bank.

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My Parkinson's disease is in the early stages.

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My condition has worsened in the last 3 years and it started less than 3 years ago.

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My Parkinson's symptoms affect my daily activities and movement significantly.

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I have early Parkinson's disease and need medication to manage it.

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I have either not been treated or only had short-term treatment with dopamine drugs.

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I can stop taking certain Parkinson's disease medications if needed for the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 31 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~31 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score

Secondary study objectives

Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Combined Score

Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score

Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II Score

+8 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TavapadonExperimental Treatment1 Intervention

Participants will receive tavapadon tablet titrated up to 15 milligram (mg) once daily (QD) orally for 27 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tavapadon

Not yet FDA approved

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Parkinson's Disease treatments primarily focus on restoring or mimicking dopamine function due to the loss of dopaminergic neurons. Levodopa is converted to dopamine in the brain, replenishing dopamine levels. Dopamine agonists, such as pramipexole and ropinirole, directly stimulate dopamine receptors. MAO-B inhibitors, like selegiline, prevent dopamine breakdown, increasing its availability. Tavapadon, a dopamine D1/D5 receptor partial agonist, specifically targets these receptors to modulate dopamine activity. These treatments are crucial for alleviating motor symptoms, improving quality of life, and potentially slowing disease progression in PD patients.

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